Tool for facilitating the connecting of a catheter or other tubular member onto a guide-wire without access to the ends of the guide-wire

ABSTRACT

An attachment tool to facilitate the attachment of a catheter or similar elongated instrument to a guide-wire or other elongated guide member, without requiring access to either end of said wire or member. Said tool providing repeatable and reliable alignment of components to be attached, while being operated with a single hand. The tool further facilitates the attachment of a plurality of catheters or instruments to a single wire or member.

[0001] RELATED APPLICATION CROSS REFERENCE

[0002] The present application is a continuation-in-part of U.S. patentapplication Ser. No. 09/523,077, filed Mar. 8, 2001, which is assignedto the same assignee as this invention and whose contents are fullyincorporated by reference herein.

FIELD OF THE INVENTION

[0003] This invention relates generally to medical devices and moreparticularly to devices for use with catheters or other tubular devicesthat are arranged to be located at some intra-lumenal, e.g.,intra-vascular, position within the body of a being by a conventionalguide-wire or other guide member.

BACKGROUND OF THE INVENTION

[0004] Heretofore the mounting of a tubular instrument, e.g., acatheter, on a guide-wire has typically required access to either thedistal or the proximal end of the guide-wire. Where the guide-wire isalready in place, access has been achieved by mounting the instrument onthe proximal end of the guide-wire and then sliding it into place overor along the guide-wire. For example, the so-called

over-the-wire

catheter (such as a balloon angioplasty catheter) has a central or otherlongitudinal extending passageway therethrough arranged to receive theguide-wire. In particular, the passageway of such a catheter isintroduced on the proximal end of the guide-wire and then the catheteris slid down the guide-wire to the desired location. The advantage ofthis type of instrument and guidance system is that it can have arelatively small cross-sectional area or

crossing-diameter,

a feature of some importance in applications wherein the lumen beingtraversed is small, e.g., an artery occluded by atheroscleroticdeposits. The so-called

mono-rail

catheter doesn't make use of a central passageway for receipt of theguide-wire, but instead makes use of some externally located connectorlocated on the distal end of the catheter and arranged to receive theguide-wire through it. The mono-rail catheter is also arranged to beintroduced on the proximal end of the guide-wire, but outside theguide-wire so that the guide-wire passes through the connector on thedistal end of the catheter, with the catheter itself being locatedbeside the guide-wire so that it can be slid along the guide-wire to thedesired location.

[0005] As will be appreciated by those skilled in the art, if theproximal end of the guide-wire has some structure permanently ortransiently mounted or secured on it, e.g., a twist or torque handle(for rotating the guide-wire to a desired angular orientation), a valve(to enable some fluid to be introduced through the guide-wire, such asto inflate a balloon on the distal end of the guide-wire), anothercatheter, etc., that is of a relatively large diameter orcross-sectional area, such a proximally mounted structure wouldnecessarily impede the mounting of the instrument over the guide-wireonce the guide-wire is in place within the being

s body.

[0006] In U.S. Pat. No. 6,022,336 (Zadno-Azis et al.) there is discloseda catheter system for revascularizing an occluded vessel and forcontaining any emboli produced during the use of the system. As bestseen in FIGS. 7 and 10A of that patent the instrument makes use ofplural catheters for providing at least one pair of paths for irrigationand aspiration fluid flow. One of the catheters, designated as an

intermediate

catheter includes an externally mounted lumen structure for receipt ofan inner catheter therethrough. This lumen structure may include alongitudinally extending slit or weakened area along the entire lengthof the lumen structure to facilitate faster and easier insertion andremoval of the inner catheter through the side wall of the lumenstructure. By inserting and removing the inner catheter through the slitin the side wall of the lumen structure, the need to remove adapters andattachments from the proximal end prior to slidably advancing orremoving the intermediate catheter over the inner catheter iseliminated. Thus, this lumen structure which is mounted at the distalend of the intermediate catheter for accommodating the inner catheterenables the intermediate catheter to be guided along the inner catheterin a manner like the heretofore discussed mono-rail catheters are slidalong a guide-wire. However, unlike the prior art devices for mountingan instrument on a guide-wire in a mono-rail like arrangement, thedevice of Zadno-Azizi et al. patent does not require access to theproximal end of the intermediate catheter or guide-wire. Instead thedevice of the Zadno-Azizi et al. patent enables the inner catheter to beinserted laterally into a longitudinally extending access slit in thelumen structure at a intermediate location along the inner catheter. Byinserting and removing the inner catheter through the slit in the sidewall of the lumen structure on the distal end of the intermediatecatheter, the need to remove adapters and attachments from the proximalend of the intermediate catheter prior to slidably advancing or removingthat catheter over the inner catheter is eliminated.

[0007] While the instrument of the Zadno-Azizi et al. patent appearsgenerally suitable for its intended purposes, it appears to leavesomething to be desired from various standpoints. For example, since thelumen structure with the access slit is located externally to theintermediate catheter it will necessarily add its diameter to thediameter of the intermediate catheter, thereby limiting its usefulnessto relatively large crossing diameter lumens. Also, the manner in whichthe intermediate catheter is attached or mounted onto the inner catheteror guide-wire may be somewhat difficult to achieve, and the additionalstructure, e.g., the slit bearing lumen structure, on the distal endcould cause the distal end to get snagged on stents placed in thevessel. Further still, since the slit through which the inner catheteror guide-wire is inserted is linear and extends longitudinally, theinner catheter or guide-wire may come out of the lumen during thetraversal of difficult anatomical orientations, e.g,. tortuous vascularpaths.

SUMMARY OF THE INVENTION

[0008] An attachment tool and method of use for facilitating theattachment of a catheter or elongated instrument having a connectorthereon to a guide-wire or other elongated guide member. The toolcomprises surfaces arranged to cause the catheter to contact theguide-wire or other elongated guide member upon the application of aforce, e.g., a twisting force, a longitudinal force, a lateral force,etc., to the tool or to the catheter or elongated instrument, whereuponthe catheter or elongated instrument is attached to the guide-wire orother elongated guide member.

DESCRIPTION OF THE DRAWINGS

[0009]FIG. 1 is an isometric view of the distal end of one embodiment ofa catheter constructed in accordance with this invention and shown afterit has been mounted on a conventional guide-wire by a helical connectorforming a portion of the distal end of the catheter;

[0010]FIG. 2 is a longitudinal sectional view of the distal end of theembodiment of the catheter shown in FIG. 1;

[0011]FIG. 3 is an isometric view of the distal end of anotherembodiment of a catheter, e.g., a beveled distal end catheter,constructed in accordance with this invention and shown after it hasbeen mounted on a conventional guide-wire by a

helical-cut

connector forming a portion of the distal end of the catheter;

[0012]FIG. 4 is a longitudinal sectional view of the distal end of theembodiment of the catheter shown in FIG. 3;

[0013]FIG. 5 is an isometric view of the distal end of still anotherembodiment of a catheter constructed in accordance with this inventionand shown after it has been mounted on a conventional guide-wire by a

pigtail

connector forming a portion of the distal end of the catheter;

[0014]FIG. 6 is a longitudinal sectional view of the distal end of theembodiment of the catheter shown in FIG. 5;

[0015]FIG. 7 is a reduced top plan view of the embodiment of thecatheter shown in FIG. 1;

[0016]FIG. 8 is an enlarged top plan view of the portion of theembodiment of the catheter shown within the area bounded by the circularbroken line in FIG. 7;

[0017]FIG. 9 is an isometric view of the distal end of the embodiment ofthe catheter shown in FIG. 1 during an initial step in the mounting ofthe catheter on the guide-wire;

[0018]FIG. 10 is an isometric view similar to FIG. 9 but showing thedistal end of the embodiment of the catheter of FIG. 1 during anintermediate step in the mounting of the catheter on the guide-wire;

[0019]FIG. 11 is an isometric view similar to FIGS. 9 and 10 but showingthe distal end of the embodiment of the catheter of FIG. 1 at a stilllater step in the mounting of the catheter on the guide-wire.

[0020]FIG. 12 is an isometric view of the distal end of anotherembodiment of a catheter constructed in accordance with this invention;

[0021]FIG. 13 is an isometric view similar to FIG. 12 but showing thedistal end of the embodiment of the catheter of FIG. 12 during aninitial step in the mounting of the catheter on a guide-wire; and

[0022]FIG. 14 is an isometric view similar to FIGS. 12 and 13 butshowing the distal end of the embodiment of the catheter of FIG. 12after the catheter has been mounted on the catheter on the guide-wire.

[0023]FIG. 15 is an isometric view of the open clamshell attachment toolshowing the internal bore and features used to direct the guide-wireinto the internal bore prior to the closing of the clamshell.

[0024]FIG. 16 is an isometric view of the catheter attached to theguide-wire inside the funnel of the closed attachment tool.

[0025]FIG. 17 is an isometric view of a guide-wire showing a pluralityof catheters connected thereon, with each catheter have a distal tipconnector such as those engaged with the attachment tool of the currentinvention.

[0026]FIG. 17A is a cross-sectional view of an embodiment of thecatheter system shown in FIG. 17, at section A-A.

[0027]FIG. 18 is an isometric view of a guide-wire showing a pluralityof catheters connected thereon, with a first catheter having a distaltip connector such as may be engaged with the attachment tool of thecurrent invention and a second catheter loaded from the end of theguide-wire.

[0028]FIG. 18A is a cross-sectional view of an embodiment of thecatheter system shown in FIG. 18, at section A-A.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] Referring now to the various figures of the drawing wherein likereference characters refer to like parts, there is shown at 20 in FIG. 1the distal end of a tubular instrument, such as an infusate catheter foruse in a intravascular revascularization system, and having a connector22 constructed in accordance with one embodiment of this invention forquickly and easily securing the catheter 20 onto a conventionalguide-wire 24 without requiring access to either end of the guide-wire.

[0030] Before discussing the details of the connector 22, it should bepointed out that the subject invention can be used with any type oftubular instrument, be it a catheter or otherwise, that is arranged tobe extended along a guide-wire or other elongated guide member into thebody of a living being to a desired location and without requiringaccess to either end of the guide-wire or other elongated guide member.In the embodiments shown herein the guide-wire 24 is shown as being atubular member, but can, if desired be a solid wire.

[0031] The infusate catheter whose distal end is shown in FIG. 1 isshown fully in the plan view of FIG. 7 and is merely exemplary of anytype of catheter or tubular instrument for which the subject inventionhas application and utility (e.g., an angiographic or other diagnosticcatheter, a drug or therapy delivery catheter, a prosthesis deliverycatheter, a revascularization catheter, a ultrasound or vascular filterwire). As best seen in FIG. 7 the catheter 20 basically comprises anelongated tubular body 20A terminating at a distal end 20B at which theconnector 22 of the subject invention is located. The opposite orproximal end of the catheter 22 is in the form of an enlarged hub orconnector 20C for connection to the associated components of therevascularization system (not shown). A central passageway 20D extendsthrough the catheter and terminates at an open free end 20E (FIGS. 7 and1). In the exemplary embodiment of catheter 20, the passageway 20D isarranged to carry an infusate liquid therethrough for ejection viaopening 20E into the portion of the vessel being revascularized ordiagnosed.

[0032] Turning now to FIG. 1 the details of the connector 22 will now beconsidered. As can be seen the connector is in the form of a helicalchannel 28 cut into the wall 30 of the catheter at the distal endportion 20B so that it is in communication with the interior passageway20D of the catheter along the entire length of the channel. The channel28 may be of fixed or variable pitch and includes a widened or flaredmouth 32 where it meets or merges with the open free end 20D of thecatheter. It is through this mouth that the guide-wire, catheter orother elongated guide member is inserted into the channel. The opposingsides of said mouth 32 may be radially offset or displaced (not shown),relative to each other, to facilitate the entry of said guide-wire 24into said channel 28. The proximal end of the channel 28 terminates inan elongated slot or exit window 34 that is also in communication withthe interior passageway 20D. It is through the window 34 that theguide-wire exits the channel. Thus, the channel forms a path into whichthe guide-wire can be inserted to slidingly connect the catheter to theguide-wire. As will be discussed in detail to follow, the path isconstructed so that the entry of the guide-wire into and through it canbe facilitated easily, quickly and reliably with only a slight twistingaction. It should be understood that the connector segment of catheter20 can be a stand-alone device which may be positioned or otherwiseattached to a portion (e.g. the distal tip) of any catheter or elongatedmember. For example, the sleeve-like tubular connector system can beprovided in a number of diameters and lengths and can be slide onto theend of a variety of compatible catheters or elongate members and thensecured in place (e.g. crimped).

[0033] In accordance with one preferred aspect of this invention thematerial making up the connector portion of catheter 20 is preferablyresilient so that the guide-wire 24 can be extended into the mouth 32 ofthe channel and then into contiguous portion of the channel 28,whereupon the channel flexes open somewhat to enable the guide-wire topass therethrough to exit from the window 34. As the guide-wire movesproximally along the channel to the window 34, portions for the channeldistally of the guide wire flexes back to the initial position,whereupon when the guide-wire is within the window, the channel willhave assumed its unflexed or normally closed condition. It should,however, be pointed out at this juncture that the catheter or thematerial forming slot need not be resilient, so long as the slot canaccommodate the guide-wire therein to enable it to slide with respectthereto, as will be described later.

[0034] In order to facilitate the exit of the guide-wire 24 from thechannel 28 at the window 34 and to ensure that the guide-wire extendsclosely parallel to the outer surface of the catheter from its exitpoint proximally, an elongate recess or depression 36 is formed in thewall 30 of the catheter 20 immediately proximally of the window 34. Therecess 36 extends along an axis parallel to the longitudinal axis of thecatheter and, as best seen in FIG. 2, inclines upward from its lowestpoint where it merges with the proximal end of the window 34 to thepoint where it terminates at the outer circular surface of the catheterproximally of the window.

[0035] In the exemplary embodiment shown the outer diameter of thecatheter is approximately 0.05 inch. The spiral channel 20 forms atleast one complete revolution about the periphery of the catheter sothat the entry mouth 32 is axially aligned with the exit window 34. Thewidth of the entrance mouth is approximately 0.025 inch. The width ofthe exit window is greater than the width of the channel 28, e.g., 0.02inch versus 0 to 0.015_inch. The length of the channel 28 measuredlongitudinally from the open end 20E of the catheter to the proximal endof the window 34 (i.e., the lowest point of the recess 36) isapproximately 0.25 inch. It should be understood that in some instancesit may be desirable that the open end 20E of the connector portion ofthe catheter be beveled or tapered to provide a good fit and smoothtransition when the catheter is advanced along to the guide-wire throughtissue or the vasculature of the living being.

[0036] In order to enable the user of the catheter to orient it in thedesired rotational attitude for mounting onto the guide-wire, a processto be discussed in detail later, an indicator marker or indicia, such asan arrow 38, is provided on the catheter aligned with the flared mouth32 so that the user of the catheter can readily determine the locationof the channel's mouth 32 by viewing the indicator arrow 38. Themounting of the catheter 20 on the guide-wire 24 will now be discussedwith reference to FIGS. 9-11. It is assumed that the guide-wire isalready in place so that its distal end (not shown) is located at someinternal situs within the body of the being, while its proximal end islocated outside the body of the being, with some intermediate portion,designated by the reference number 24A herein, also being locatedoutside the body of the being distally of the proximal end of theguide-wire. It is at this intermediate position that the catheter 20 ismounted on the guide-wire using the connector 22. It should be pointedout at this juncture that while the portion 24A of the guide-wire ispreferably outside the body of the being, such an arrangement is notrequired. In this regard in some medical applications the guide wireportion 24A where the catheter is to be connected may be locatedinternally of the being and access provided to it via a natural bodyorifice or opening or through some surgically formed opening.

[0037] In any case, as best seen in FIG. 9 the catheter 20 is orientedor twisted so that the entry mouth 32 at the distal end of the channelis aligned with the portion 24A of the guide-wire 24. The arrow indicia38 facilitates the correct orientation alignment procedure. Once alignedthe distal end of the catheter 20 is moved in a lateral direction (e.g.,from the side of the guide-wire) toward it (or the guide-wire is movedtoward the catheter) so that the guide-wire portion 24A enters into themouth of the channel 116. Then the catheter is twisted or rotated in thedirection shown by arrow 40 to cause the guide-wire portion 24A to enterinto the contiguous portion of the channel 28, whereupon the channelflexes open, as described earlier. Continued twisting of the catheter inthe direction of arrow 40 causes the guide-wire to move further down thechannel as shown in FIG. 11. Continued twisting of the catheter withrespect to the guide-wire in the direction of arrow 40 eventually bringsthe guide-wire portion 24A into the exit window 32, as shown in FIGS. 1and 2, whereupon the guide-wire portion 24 exits the window and isguided upward by the inclined recess 36 until it is generally parallelto the outer surface of the catheter 20 (as best seen in FIG. 1). Oncethis has been accomplished, the catheter can be slid or moved in thedistal direction along the guide-wire to bring the open distal end 20Eof the catheter to the desired position within the being's body, e.g.,at a situs of the atherosclerotic deposit to be removed.

[0038] In FIGS. 3 and 4 there is shown an alternative embodiment of acatheter 20′ constructed in accordance with this invention. The catheter20′ is in all material respects identical to the catheter 20, except forthe shape of its distal end. Thus, in the interest of brevity thedetails of the construction and the operation of the catheter 20′ willnot be reiterated and the same reference numbers will be given to thecommon components. As can be seen in FIGS. 3 and 4 the distal end of thecatheter 20′ includes a beveled end 20E′. The entry mouth to the channel28 is located on the most proximal portion of the beveled end 20E′ forinitial receipt of the guide-wire portion 24A therein.

[0039] In FIGS. 5 and 6 there is shown another embodiment of a catheter100 constructed in accordance with this invention. The catheter 100 alsoincludes a connector 102 (to be described in detail hereinafter) forfacilitating the mounting of the catheter on a portion 24A of theguide-wire from a lateral or side direction and without requiring accessto either end of the guide-wire. However, unlike the embodiments ofFIGS. 1-4, the connector 102 of the catheter 100 is located externallyto the outer surface of the distal end of the catheter 100 to form thepath or channel for the guide-wire therebetween.

[0040] The connector 102 basically comprises a helical wire havingplural consecutive helices 104 and terminating at one end in a distalend portion 106 and at the opposite or proximal end portion 108. Thedistal end portion 108 is linear and is centrally disposed within thehelices 104 (See FIG. 6). The distal end portion is arranged to befixedly secured in a central bore 110 in the distal end of the catheter100. As can be seen the distal end of the catheter is closed, e.g., itincludes a dome-shaped end wall 112 into which the bore 110 extends.Since the end of the catheter 100 is closed, if it is to be used as aninfusating device it includes plural outlet ports or openings 116extending through the sidewall 30 of the distal end portion and incommunication with the central passageway 118 of the catheter. Thehelices 104 extend backward from the distal end portion 106 of theconnector 102 and about the periphery of the outer surface of thecatheter 100 to form an annular space or channel 120 therebetween. Thethickness of the channel is just slightly greater than the outsidediameter of the guide-wire (for reasons to be explained later). Theproximal end portion 108 terminates in a somewhat bulbous free end 122which is also spaced from the outer surface of the catheter and whichforms the entry mouth for the channel 120. The connector 102 may beformed of any suitable biocompatible material, e.g., stainless steel,plastic, etc.

[0041] The mounting of the catheter 100 on the guide-wire portion 24A isaccomplished by orienting or aligning the catheter 100 so that theguide-wire portion can be inserted into the entry mouth, i.e., the spacebetween the bulbous distal free end 122 of the connector 102 and theouter surface of the catheter 100. Once aligned the distal end of thecatheter 100 is moved in a lateral direction (e.g., from the side of theguide-wire) toward it (or the guide-wire is moved toward the catheter)so that the guide-wire portion 24A enters into the mouth of thechannel120. Then the catheter 100 is twisted or rotated in the directionshown by arrow 40 to cause the guide-wire portion 24A to enter into thecontiguous portion of the channel 120, i.e., the helical portion definedby the helix closest to the free end 122. Continued twisting of thecatheter in the direction of arrow 40 causes the guide-wire to movefurther down the channel, guided by the helices 104 until it exits fromthe channel at the distal most helix 104. At this time the guide-wirewill be within the confines of the channel and disposed parallel to andvery closely adjacent to the outer surface of the catheter. Once thishas been accomplished, the catheter 100 can be slid or moved in thedistal direction along the guide-wire 24 to bring the distal end of thecatheter to the desired position within the being's body, e.g., at asitus of the atherosclerotic deposit to be removed.

[0042] In accordance with one preferred aspect of this invention thediameter of the wire making up the connector 102 is quite small, e.g.,0.010 inch, and the thickness of spacing between the inner surfaces ofthe connector's helices 102 and the outer surface of the catheter 100(i.e., the thickness of the annular channel 120) is just slightly largerthan the outside diameter of the catheter. Thus, the catheter 100 withthe connector 102 thereon will still exhibit a small crossing diameter(albeit somewhat greater than a comparable diametrically sized cathetermaking use of the connectors like shown in FIGS. 1-4).

[0043] In FIGS. 12-14 there is shown yet another alternative embodimentof a catheter 200 constructed in accordance with this invention. Thecatheter 200 is similar to the catheter 20 in that it is a hollowtubular member having a central passageway 20D terminating at an opendistal end 20E, yet is also similar to the catheter 100 in that catheter200 includes an externally located connector 202. The connector 202 islike the other connectors described heretofore arranged to enable aguide wire 24 or other elongated guide member to be readily connected tothe catheter by inserting it into a path (to be described hereinafter)by a twisting action, whereupon the catheter or other instrument can beslid along the guide-wire or other elongated guide member, yet isresistant to accidental disconnection.

[0044] As can be seen the connector 202 basically comprises a sleeve 204formed of any biocompatible material, like those described heretofore,and having a pair of fingers 206 and 206 projecting outward therefrom.The sleeve 204 includes a circular central passageway whose insidediameter is approximately the same as the outside diameter of the distalend portion of the catheter 200 to accommodate that portion of thecatheter extending therethrough. The sleeve is secured in place by anysuitable means, e.g., an adhesive, by friction fit, etc. Moreover, thesleeve may be integrally formed on the distal end portion of thecatheter. In fact, as will be appreciated from the discussion to follow,the use of a sleeve may be eliminated if the connector is formedintegrally with the catheter. In such an arrangement, all that isrequired is that distal end of the catheter include the fingers 206 and208 to form the guide-wire receiving path.

[0045] Each of the fingers 206 and 208 projects outward from thelongitudinal axis of the connector and the longitudinal axis of thedistal end of the catheter 200. Each of the fingers includes anoverhanging, e.g., arcuate, free end 210. The free end of the respectivefingers are directed in opposed directions to each other, i.e., they aredirected so that they face each other but are offset from each other inthe longitudinal direction. In particular, the free end 210 of thefinger 206 is directed from one side of the catheter 200 towards thefree end 210 of the finger 208 on the other side of the catheter. Thefingers 206 and 208 may extend tangentially, radially or at some otherorientation away from the central longitudinal axis of the catheter 200so that the free end 210 of the finger 206 and the free end 210 of thefinger 208 each form a respective portion of a channel or path 212between them and the portion of the sleeve from which they project (orfrom the portion of the catheter from which they project if no sleeve isutilized, e.g., the fingers are formed integrally with the catheter 200.

[0046] In the preferred embodiment shown herein the path 212 is of agenerally circular cross-section and extends linearly along thelongitudinal axis of the catheter immediately adjacent the outer surfaceof the sleeve 204. It is in this channel or path 214 that the guide-wireportion 24A of the guide-wire 24 is arranged to be inserted to slidinglymount the catheter on the guide-wire. In accordance with a preferredembodiment of this invention the free ends 210 of the fingers 206 and208 extend around the periphery of the guide-wire so that the fingersand contiguous portion of the sleeve each engage or encircle more than180 degrees of the periphery of the guide-wire when the guide-wire iswithin the path or channel to prevent the guide-wire from accidentallycoming out of the path or channel. The entry point or entrance to thepath or channel 212 is provided by the space or gap 214 between thefingers 206 and 208.

[0047] In order to minimize the crossing-diameter of the catheter 200,the fingers 206 and 208 of the connector are preferably dimensioned tokeep their height or projection from the central longitudinal axis ofthe catheter 200 as short as possible, while still enabling theguide-wire portion 24A to be held securely in the path 212 for slidingmovement resistant to accidental disconnection. Thus, in the preferredembodiment shown in the cross-sectional area of the channel 212 is justslightly larger than the outside diameter of the guide-wire 24A and thefingers are very thin.

[0048] The connection of the catheter 200 to the guide-wire portion 24Awill now be described with reference to FIGS. 13 and 14. As before, itis assumed that the guide-wire 24 is already in place so that its distalend (not shown) is located at some internal situs within the body of thebeing, while its proximal end is located outside the body of the being,with the intermediate portion 24A of the guide wire also being locatedoutside the body of the being distally of the proximal end of theguide-wire. As pointed out earlier while the portion 24A of theguide-wire is preferably outside the body of the being, such anarrangement is not required. In this regard in some medical applicationsthe guide wire portion 24A where the catheter is to be connected may belocated internally of the being and access provided to it via a naturalbody orifice or opening or through some surgically formed opening.

[0049] In any case, as best seen in FIG. 13 the catheter 202 is orientedso that the entry mouth or gap 214 of the path 212 at the distal end ofthe channel is aligned with the portion 24A of the guide-wire 24, e.g.,the longitudinal axis of the guide-wire portion 24A is perpendicular tothe longitudinal axis of the catheter 200 and is between the fingersforming the gap. Once so aligned the distal end of the catheter 20 istwisted about an axis perpendicular to the longitudinal axis of thecatheter to bring the more distally located portion of the guide-wireportion 24A into the path 212 under the finger 206, while at the sametime bringing the more proximally located portion of the guide-wireportion 24A into the path 212 under the finger 208 as shown in FIG. 14.This action completes the sliding securement of the catheter on theguide-wire 24. Therefore, once the sliding securement has beenaccomplished, the catheter 200 can be slid or moved in the distaldirection along the guide-wire 24 to bring the open distal end 20E ofthe catheter to the desired position within the being

s body, e.g., at a situs of the atherosclerotic deposit to be removed.

[0050] It should be pointed out at this juncture that while theforegoing discussion has described the twisting of the catheter or othertubular instrument with respect to the guide-wire or other elongatedguide member to releasably secure the two together, that methodology isnot the only method for achieving their releasably securement. Thus, aswill be appreciated by those skilled in the art, the guide-wire or otherelongated guide member can be twisted with respect to the catheter orother tubular instrument to cause the guide-wire or other tubularinstrument to be introduced into the path for holding the two together.

[0051] It should also be pointed out that while the foregoing discussionhas described catheters or other tubular instruments with the varioustypes of connectors forming a portion thereof, it should be clear thatconnectors, per se, may be constructed in accordance with this inventionfor mounting, e.g., retrofitting, to existing catheters or other tubularinstruments. Thus, the subject invention not only contemplates cathetersor other elongated tubular instruments including connectors forconnecting the catheters or other tubular instruments to guide-wires orother elongated guide member, but also contemplates connectors, per se,for use with conventional catheters to achieve those ends.

[0052] In a preferred embodiment an attachment tool 300 comprises ahinged clamshell construction, that when closed provides for an interiorlongitudinal bore 301 for the guide-wire (or other elongated guidemember) that expands into a conical funnel portion 302 at the leadingend (proximal end) 310 of the tool. The tool further comprises twohalves, a first half 303 on which is located on a pair of raised v-shapeprotrusions 304 through which the guide-wire 24 is placed into the bore301. The raised protrusions 304 are arranged co-linear with a bore 301,and on either side of same, to allow for easy placement of saidguide-wire, and also engage the second half of the tool 305 in a matingdepressed portion 306. The engagement of the protrusion of the firsthalf and the depression of the second half, during closing of the tool300 by rotating 330 one half of tool, serve to align the closed tool,thereby creating a smooth funnel opening 302, or catheter entry port.Living hinges 307 allow for one-handed closure of the tool around theguide-wire 24 (not shown), a small indentation 308 provides for a tab toopen the closed tool to remove it from the attached catheter-guide-wireapparatus. The bore 301 extends the full length of the first half 303,and can be utilized for guide-wire alignment at the distal end 309opposite the funnel opening 302.

[0053] The tool 300 is intended to be closed over the guide-wire 24, asis shown in FIG. 16, whereby the guide-wire shall then reside within thebore 301 inside the closed tool. The catheter 20 containing the distaltip connector 28 (e.g., one of the various embodiments previouslydescribed) is then advanced into the open funnel portion of the tool302, and the catheter is simultaneously advanced 311 and twisted 40 toeffect attachment of the connector 310 to the guide-wire (as previouslydescribed). The conical funnel 302 serves to press the catheter againstthe guide-wire, facilitating the entry of the guide-wire into the mouth32 provided at the entry of the helical channel 28.

[0054] In yet another embodiment, said attachment tool 300 causesalignment of said guide-wire 24 and said catheter 20, as shown in FIG.16; however, the tool of this embodiment further utilizes a detent tofacilitate engagement of said guide-wire 24 with said channel 28,wherein said detent comprises a mouth 32 (as shown in FIG. 1) or anoffset (not shown), as previously described herein.

[0055] Once the catheter is fully attached, the tool is then opened withtab 308 to release the guide-wire, and the catheter can be advanced orretracted freely and securely along the wire. This exemplary toolembodiment is designed to be functional and easy-to-use with one hand,but other embodiments causing contact and engagement of the catheter andwire are anticipated and within the concept of the present invention.

[0056] The attachment tool 300 may be sized to allow its insertion intoa natural body orifice, or other surgical created entry site, whereinsaid tool may attach a plurality of catheters while said tool is locatedentirely inside of the body. It is within the concept of this inventionto operate the attachment tool with hands, fingers, or otherinstruments, thereby enabling the attachment of catheters to aguide-wire at various remote areas within the body.

[0057] The longitudinal bore 301 arranged therebetween the proximal anddistal ends of said tool 300 allows communication through the tool. Thiscommunication allows catheters or other instruments comprisingfunctional members (not shown) located distal to the distal tipconnector, and attached thereto, to be arranged in the bore 301 suchthat said member extends through the distal end 309 of said tool 300. Asa non-limiting example, said functional member may comprise a steeringtip (for steering the functional member, and catheter, independently ofguide wire 24), an angioplasty balloon (with or without a steering tip,which may be used to occlude an arterial branch), or a catheter for thedelivery of a therapy or diagnostic equipment (e.g., a drug,biologically active agent, radioactive source, ultrasonic source, orother prosthesis).

[0058] Since the distal tip connector, as previously described, does notneed access to the ends of the guide-wire, a plurality of catheters maybe attached to the guide-wire while the guide-wire is in-place (i.e.,extending into the body, to the site of the procedures) withoutrequiring access to the end of the guide-wire. A preferred embodiment ofthe attachment tool, of the present invention, facilitates thisattachment.

[0059] As an example, FIG. 17 shows a plurality of catheters eachcomprising a channel-type of distal tip connector 28 (such as that shownin FIG. 1); wherein a guide-wire 24 has a first catheter 400 attached(said first catheter may contain a radio-opaque marker 401, to ease theloaction of said catheters during the procedure), and a second catheter410 attached proximally to said first catheter. The attachment tool 300(as shown in FIGS. 15-16) facilitates this multiple catheter system, andthe number of catheters is limited only by the crossing diameter of theartery.

[0060] The benefits of this attachment tool and this type of multiplecatheter system can readily be seen in FIG. 17A, wherein thecross-section shows the non-concentric arrangement of the catheters andguide-wire. As previously described, the flow or access through thecatheters is not impeded, that is, neither the first catheter 400, northe second catheter 410 need to house other catheters or guide-wires.The guide-wire 24 enabling the placement of said catheters is externalto each catheter. The first catheter's flow 404, as well as the secondcatheter

s flow 414, remains unrestricted.

[0061] This free flow through a plurality of catheters allows orimproves the ability to perfuse diagnostic or therapeutic fluids anddrugs. Additionally, higher pressures and/or flow rates facilitates theremoval of fluids and/or debris. As an example, FIG. 18 shows aplurality of catheters on a single guide-wire. A guide-wire 24 has afirst catheter 400 attached, and a second catheter 420 attachedproximally to said first catheter. However, in this figure the firstcatheter 400 is attached via a channel-type of distal tip connector 28,while the second catheter 420 is threaded over the guide-wire 24 in amore traditional concentric loading configuration.

[0062] The concentric loading method restricts the flow; as can be seenin FIG. 18A, the second catheter 420 loaded over the guide-wire 24 hasreduced flow 424 characteristics, when compared to the first catheter'sflow 404.

[0063]FIG. 18 also shows an example of a procedure capable with aplurality of catheters. A distal balloon 406 provides protection fromdebris 403 travelling distally from the procedure, which may cause astroke, heart attack, or other pulmonary event. Said debris 403 beingliberated from a plaque deposit 402 by fluid flow 434 emanating from thedistal opening 404 of the first catheter 400 (said flow 434 may becomplemented by additional flow 34 from the proximal end or window 34located at the proximal end of said distal tip connector 28); saiddebris 403 being removed with the artery or vessel along with the debrisstream 422 through the distal opening 424 in the second catheter 420.This figure is merely exemplary of the benefits of a multiple cathetersystem, while it is recognized that it may not be as efficient as asystem employing multiple non-concentric catheters, as is shown in FIG.17; all of which is facilitated by an embodiment of the attachment tool300 of the present invention.

[0064] Without further elaboration the foregoing will so fullyillustrate our invention that others may, by applying current or futureknowledge, adopt the same for use under various conditions of service.

We claim:
 1. An attachment tool for facilitating the attachment of acatheter or elongated instrument arranged with a connector thereon to aguide-wire or other elongated guide member, said tool comprising alongitudinal bore arranged to accept a guide-wire or other elongatedguide member, a funnel shaped entry port section for facilitating entryof the catheter or instrument therein, said port being in communicationwith said bore, said port being arranged to cause said guide wire orother guide member to contact said catheter or instrument upon insertionof said catheter or instrument into said tool, said port and borecooperating with each other whereupon said contact engages saidconnector.
 2. In combination with the tool of claim 1, the catheter orelongated instrument, and wherein said connector of said catheter orelongated instrument comprises a helical channel for connecting saidguide-wire or other elongated guide member to said catheter or elongatedinstrument.
 3. In combination with the tool of claim 1, the catheter orelongated instrument, and wherein said connector of said catheter orelongated instrument comprises a helical wire for connecting saidguide-wire or other elongated guide member to said catheter or elongatedinstrument.
 4. An attachment tool for facilitating the attachment of acatheter or elongated instrument arranged with a connector thereon to aguide-wire or other elongated guide member, said tool comprisingsurfaces arranged to cause said catheter to contact said guide-wire orother elongated guide member upon the application of a force to saidtool or said catheter or elongated instrument, whereupon said catheteror elongated instrument is attached to said guide-wire or otherelongated guide member.
 5. The tool of claim 4, wherein said tool orsaid catheter or elongated instrument is arranged to have a twistingforce applied thereto to attach said catheter or elongated instrument tosaid guide-wire or other elongated guide member.
 6. The tool of claim 4,wherein said tool or said catheter or elongated instrument is arrangedto have a longitudinal force applied thereto to attach said catheter orelongated instrument to said guide-wire or other elongated guide member.7. The tool of claim 4, wherein said tool or said catheter or elongatedinstrument is arranged to have a lateral force applied thereto to attachsaid catheter or elongated instrument to said guide-wire or otherelongated guide member.
 8. In combination with the tool of claim 4, acatheter or elongated instrument having a detent thereon, and whereinsaid attachment is facilitated by said detent.
 9. The tool of claim 8,wherein said detent comprises at least one of an offset and a mouth. 10.An attachment tool for facilitating the attachment of a catheter orsimilar elongated instrument arranged with a distal tip connectorthereon to a guide-wire or other elongated guide member, said toolcomprising a first and second half, a hinge is arranged to connect saidhalves, said hinge allowing relative pivoting of said first half withrespect to said second half such that said halves come together closingsaid tool, said first half comprising a pair of raised V-shapeprotrusions, said second half comprising a depression wherein saidprotrusions are forced into said depression upon the closing of saidtool, thereby causing alignment of said first and second halves, saidfirst half further comprising a longitudinal bore arranged to accept aguide-wire or other elongated guide member, said tool further comprisinga proximal end and a distal end, said first and second halves eachfurther comprising a half-funnel shaped entry port section located atthe proximal end of said tool, whereby both of said entry port sectionscreate a smooth funnel shaped entry port for facilitating entry of saidcatheter or elongated instrument therein, said entry port being incommunication with said with said bore, said port being further arrangedto guide said catheter or elongated instrument to said guide-wire orother elongated guide member to facilitate attachment.
 11. Incombination with the tool of claim 10, a catheter or elongatedinstrument having a distal tip connector, said distal tip connectorcomprising a helical channel located at the distal end of said catheteror elongated instrument.
 12. In combination with the tool of claim 10, acatheter or elongated instrument having a distal tip connector, saiddistal tip connector comprising a helical wire located at the distal endof said catheter or instrument.
 13. A method of facilitating theattachment of a catheter or elongated instrument to a guide-wire orother elongated guide member, without having access to the ends of saidwire or member, comprising: a) supplying an attachment tool comprising afirst and second half, a arranged to connect said halves, said hingeallowing relative pivoting of said first half with respect to saidsecond half such that said halves come together closing said tool, saidfirst half comprising a pair of raised V-shape protrusions, said secondhalf comprising a depression wherein said protrusions are forced intosaid depression upon the closing of said tool, thereby causing alignmentof said first and second half, said first half further comprising alongitudinal bore arranged to accept a guide-wire or other elongatedguide member, said tool further comprising a proximal end and a distalend, said first and second halves each further comprising a half-funnelshaped entry port section located at the proximal end of said tool,whereby both of said entry port sections create a smooth funnel shapedentry port for easy catheter or instrument insertion, following theclosing of said tool with said guide-wire or member located between saidprotrusions, said entry port arranged to guide said catheter orinstrument to said guide-wire or elongated guide member, to facilitateattachment of said distal tip connector thereon; b) supplying a catheteror instrument to be attached to a guide-wire or elongated guide member;c) closing said attachment tool on said guide-wire or elongated guidemember; d) inserting said catheter or instrument into said entry portand applying a force thereto until resistance is felt; and e) openingsaid tool and removing wire or member from said longitudinal bore.
 14. Amethod of facilitating the attachment of a catheter or elongatedinstrument to a guide-wire or other elongated guide member, withouthaving access to the ends of said guide-wire or elongated guide member,comprising: a) supplying an attachment tool comprising a longitudinalbore, an entry port in communication with said bore, and surfacesarranged to cause said catheter to contact said guide-wire or elongatedguide member upon the application of force thereto, said contact therebyeffecting attachment; b) supplying a catheter or elongated instrument tobe attached to a guide-wire or elongated guide member; c) closing saidattachment tool on said guide-wire or elongated guide member; d)inserting said catheter or elongated instrument into said entry portwhile applying force until resistance is felt; and e) opening said tooland removing said guide-wire or elongated guide member from saidlongitudinal bore.
 15. The method of claim 14, wherein said guide-wireor elongated guide member is located outside the body
 16. The method ofclaim 14, wherein said guide-wire or elongated guide member is locatedinside the body
 17. The method of claim 16, wherein said attachment toolis arranged for location inside the body, said method furthercomprising: f) removing said tool from inside said body.
 18. The methodof claim 14, wherein said force comprises twisting.
 19. The method ofclaim 14, wherein said force comprises longitudinal force.
 20. Themethod of claim 14, wherein said force comprises lateral force.
 21. Amethod of facilitating the attachment of a plurality of catheters orelongated instruments to a guide-wire or other elongated guide member,without access to the ends of said guide-wire or other elongated guidemember, comprising the method of claim 13, wherein said method furthercomprises: f) re-closing said attachment tool on said guide-wire orelongated guide member; g) inserting a second catheter or elongatedinstrument into said port while applying force until resistance is felt;and h) opening said tool and removing said guide-wire or elonaged guidemember from said longitudinal bore.